■ OBJECTIVES: The efficacy of the Otologics Fully-Implantable METä Hearing Device was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss.

■ METHODS: Surgical insertion of this totally implanted electromechanical transducer is the same as in the Phase I study and included: An Atticotomy to expose the incus, secure the transducer to the mastoid bone, attach the transducer tip to the incus via insertion into a laser drilled hole, and post auricular implantation of the microphone/battery/electronics capsule. A repeated-measures within-subjects design assessed aided sound field thresholds and  peech performances with the subject’s own, appropriately fit, walkin hearing aid(s) and the Otologics Fully-Implantable Hearing Device.

■ RESULTS: Initial (2 month activation) Phase II data will be presented. 10 patients were implanted and activated as part of the Otologics Fully-Implantable METä Hearing Device Phase II clinical trial. No significant differences between preoperative (AC = 59 dB, BC = 55 dB) and postoperative (AC = 61 dB, BC = 54 dB) unaided pure tone averages were noted (p <0.05). Pure tone average implant aided thresholds (41 dB) were equivalent to that of walk-in-aided (37 dB) condition with no significant difference (p <0.05) between patients’ walk-in-aided individual frequency thresholds and implant aided thresholds. At activation, word recognition scores were better for the walk-in-aided condition but are expected to improve for the implantaided condition with acclimatization at the 3 month data point. Patient benefit scales will be presented as collected at the 3 and 6- month end points.

■ CONCLUSIONS: Preliminary results of the Otologics MET Fully- Implantable Hearing Device Phase II trial provide evidence that this fully implantable device may be a desirable alternative to currently available hearing aids in patients with sensorineural hearing loss.